IN THE COURT OF COMMON PLEAS

OF PHILADELPHIA COUNTY
CIVIL TRIAL DIVISION
MIA ROBINSON, et al.

:
:
:
:
:
:

vs.
WOLTERS KLUWER
HEALTH INC., et al.

JULY TERM, 2011

NO. 778

CONTROL NO. 14123047

MEMORANDUM OPINION
Mia Robinson was born with severe heart defects. During pregnancy her mother took
Zoloft for depression. The defendants claim the testimony of plaintiffs experts on general and
specific causation fail to meet the methodological requirements for admissibility of scientific
opinion testimony and should be precluded at trial.1
The Frye test, adopted into Pennsylvania in the case of Commonwealth v. Topa,2 has been clearly
explained by the Supreme Court of Pennsylvania in Grady v. Frito-Lay,3 and the Superior Court
in Trach v. Fellin.4
The Frye5 test is an evidentiary standard for determining whether the methodology
employed by a proposed witness is considered scientific by others in a relevant scientific field.
1 No challenge is presented to the qualifications of any of the highly qualified experts.
2 471 Pa 223, 369 A,2d 1277. (1977)
3 576 Pa. 546 839A.2d 1038 (2003)
4817 A.2d 1102 (2003).
1

The Frye standard to determine whether scientific expert testimony will help the jury6 is not
applicable to all expert testimony. Although the proponent of evidence bears the burden of
proving admissibility,7 this admissibility standard applies only when novel science is
proposed.8 The Frye standard does not involve any Judicial finding of the accuracy of the
ultimate opinion. It is only the methodology employed which is to be evaluated, not the
conclusions reached.9 The initial formulation of the Frye Court continues to be instructive:
Just when a scientific principle or discovery crosses the line between the experimental
and demonstrable stages is difficult to define. Somewhere in this twilight zone the evidential
force of the principle must be recognized, and while courts will go a long way in admitting
expert testimony deduced from a well-recognized scientific principle or discovery, the thing
from which the deduction is made must be sufficiently established to have gained general
acceptance in the particular field in which it belongs.
The Pennsylvannia Frye test for admissibility does not require this Court to independently
determine the Judges understanding of the science of epidemiology, teratology or statistics as
applied to the facts of Mia Robinsons birth defects. Unlike Courts which have adopted the
Daubert 10 standard, this Court may not independently analyze or evaluate peer reviewed journal
articles or other scientific material except as they relate to the methodology employed by the

5 Initially formulated in U.S. v Frye, 293 F. 1013 (D.C. Cir, 1923.

6 See Pa.R.E. 702.
7 Grady v. Frito-Lay, 576 Pa. 546 839 A.2d 1038 (2003).
8 Trach v. Fellin, 817 A.2d 1102 (2003).
9 See Trach v. Fellin, specifically overruling Mackenzie v. Westinghouse, 674 A.d 1167 (Pa. Cmwlth.
1996)
10 Daubert v. Merrill Dow Pharmaceuticals Inc., 509 US 579, 113 S.Ct. 2786, 125 L.Ed 2d 469 (1993).
2

proposed expert witnesses in reaching conclusions. Thus as detailed by Justice Cappy in Grady
v. Frito-Lay, the Frye test is comparable to other common Judicial functions.
Writing for the Court in Grady v. Frito-Lay Justice Cappy said:
One of the primary reasons we embraced the Frye test in Topa was its assurance
that Judges would be guided by scientists when assessing the reliability of a scientific
method.
We believe now, as we did then, that requiring judges to pay deference to the
conclusions of those who are in the best position to evaluate the merits of scientific
theory and technique when ruling on the admissibility of scientific proof, as the Frye rule
requires, is the better way of insuring that only reliable expert scientific evidence is
admitted at trial.
We also believe that the Frye test, which is premised on a rule-that of general
acceptance is more likely to yield uniform, objective, and predictable results among the
courts, than is the application of the Daubert standard, which calls for a balancing of
several factors. Moreover, the decisions of individual judges, whose backgrounds in
science may vary widely, will be similarly guided by the consensus that exists in the
scientific community on such matters.
Although both the Frye and Daubert standards relate to methodology and not
conclusions, the differences are dramatic. Under the Frye standard this Court is required to
perform fact finding only as to the synchronicity of proposed expert testimony with acceptable
scientific investigation.11 Pursuant to the Daubert standard scientific consensus does not per se
permit opinion testimony. A scientific consensus that proper methodology was employed is only
one of several nonexclusive criteria for determining whether the expert testimony will assist
the jury. The Daubert standard requires the court to make an independent judicial scientific
judgment whether the methodology is scientifically sound even if a scientific consensus of
propriety exists. Judges with different understanding of scientific processes can make different
11 Like preliminary rulings as to authenticity (Pa. R.E. 901 et. seq. or personal knowledge (Pa R.E. 602) the Court
may not preclude opinion testimony because the Judge disagrees with the testimony. Judges in jury trials should
not exclude expert testimony simply because they disagree with the conclusions of the expert. Betz v. Pneumo
Abex, LLC, 615 Pa. 504, 542-43, 44 A.3d 27, 51 (2012).

rulings on the same opinion subject only to an abuse of discretion appellate review standard.12
Pursuant to the Frye standard the Court need only determine whether an appropriate scientific
community considers the methodology used to reach an opinion is scientifically sound. To be
available for jury evaluation the methodology employed by the expert must be scientifically
acceptable.13
Real scientific knowledge is not and never has been static. Even using proper methodology
scientists routinely disagree and even reach different conclusions while accepting the same
underlying data as accurate. Through the interaction of differing but scientifically appropriate
conclusions derived from commonly accepted data, knowledge progresses. Likewise different
scientific disciplines may properly opine on the same questions using different but proper
methodologies.
Thus, the trial court faces two primary questions in any Frye analysis:
1. Is the data and other underlying information relied upon the type of data properly relied
upon in a scientific discipline appropriate to the question presented for jury
determination? And;
2. Was this proper data analyzed in accord with a scientific discipline appropriate to the
question presented for jury determination?
In this case Plaintiffs expert Dr. Jewells methodology used to conclude that Zoloft taken
during pregnancy can be the cause heart birth defects is challenged.14 Dr. Jewell based his
12 General Electric Co., v. Joiner, et ux, 118 S.Ct. 512, 177A.L.R. Fed. 667, 139 L.Ed.2d 508, 66 USLW
4036.
13 Perfect or ideal is not the standard, See Trach v. Fellin, 817 A.2d 1102 (2003).
14 It was agreed in conference that the Court ruling concerning Dr. Jewell also would apply to Dr.
Finnell, Dr. Cabera and Dr. Kapper because they use a commensurate methodology. This was
incorporated in an Order dated February 10, 2015.
4

analysis upon the same publicly available peer reviewed medical literature used by defense
experts and by defendant Pfizer itself in internal documents. Dr. Kimmel, the primary defense
expert witness at the Frye hearing agreed that the appropriate first step in determining whether
Zoloft is teratogenic is to identify the relevant literature.15 Dr. Kimmel agreed that Dr. Jewell
reviewed the appropriate literature: Yes I listened so I certainly know Dr. Jewell and I looked at
the same literature.16 Pfizers qualified expert employees also looked at that same literature.
These expert employees found 81 potentially relevant studies, abstracts, and papers of which 68
were not determined to be useful. The same thirteen studies formed the relevant literature used
by plaintiffs experts, defense experts, and Pfizer scientists.
Dr. Jewell analyzed these peer reviewed published studies which compared different
populations and performed different analyses. Defendant Pfizers litigation experts and scientists
analyzed the same body of literature to their conclusions. Defendant Pfizers May 2014 internal
document entitled Response to Pharmacological Risk Assessment Committee (PRAC)
cumulative Review of Growth Retardation In Children and Adolescents17 describes18 a
comparable methodological review of the same literature and reports a remarkably compatible
conclusions to that of Dr. Jewell namely .a consistently positive association has been found
for sertraline exposure and cardiovascular defects, especially septal defects.
Of these relevant studies, six demonstrated positive associations between sertraline
during pregnancy and teratogenic effects.
15 N.T., 2/18 2015, 74: 21-75:2
16 N.T., 2/18 2015, 75: 6-15.
17 P-1 at the Frye hearing.
18 At pages 42-43.
5

Dr. Kimmel agreed that some of these studies showed positive associations.
Q. It says, some studies have found associations between sertraline use during
pregnancy and particular birth defects, is that what it says
A. Yes it does.
Q Do you agreed with that?
A. Yes.19
Although Dr. Kimmel disagreed with the Pfizers scientists who found an association he
provided no description of any differences between Pfizers scientific methodology or that used
by Dr. Jewell.20

Dr. Jewell evaluated the studies which showed positive associations between Zoloft and
heart birth defects and also evaluated the studies which revealed negative associations or were
inadequate to formulate any scientific opinion. Dr. Jewell considered whether the positive
associations were a function of random variation or chance. He evaluated possible confounding
factors including detection bias, smoking, obesity, and confounding due to the underlying
condition which caused Zoloft to be prescribed. Dr. Kimmel concedes that this next step in a
methodological evaluation is also appropriate.
Q. Dr. Jewell took these positive associations in his methodology and then assessed
them for chance, bias, confounding, correct?
A. He did apply those ideas.21

19 N.T., 2/18, 2015 84: 10-15.

20 Q. This paper that you reviewed earlier P-1, also says when focusing on a specific defect a consistently positive
association has been found for sertraline exposure and cardiovascular defects especially septal defects. Do you
disagree with that conclusion? A. Yes. N.T., 2/18 15 74/7-13.

21 N.T., 2/18 2015 95-15-20.

Dr. Jewell evaluated other possible explanations for the association. Although Dr.
Kimmel equivocated, he finally agreed that Dr. Jewells procedure, although debatable, was
acceptable science.
Q.That was one of the methods by which Kornum attempted to address [confounding by
indication]; is that correct?
A.
That is.
Q.
And that is a generally well-accepted methodology for testing confounding by
Indication, isnt it?
A.
It is a method. It is an inferior method to others, because confounding by
COURT:

Wait, wait, wait. The question was, isnt it, and the answer is yes, isnt it?

WITNESS:
COURT:
WITNESS:
COURT:

I would say theres some debate in the pharmacoepidemiology world.

Is there a debate in your professional opinion?
Yes.
So you dont have an opinion about whether [thats] acceptable or not?
Youre not certain. Is that
I am uncertain.
You cant testify to a reasonable degree of scientific certainty whether
thats an acceptable methodological method, correct?

WITNESS:
COURT:
WITNESS:

Yeah, its a method, yes. Its an acceptable method.22

Indeed Dr. Kimmel admitted that he has used that same methodology in one of his own
published peer reviewed articles.23
Finally, Dr. Jewell analyzed whether the demonstrated associations represent an actual
causal connection. Dr. Jewell evaluated the literature in accordance with commonly accepted
criteria for evaluating causation, the Bradford Hill criteria, to determine whether the positive

22 Tr. 2-18-2015 p.m. at 19:21-21.3.

23 N.T. 2/18/15 21:4 12.
7

association is a product of chance or bias. Defendant expert Dr. Deepak Srivastava agreed that
this is a proper criteria.24
Conclusions contained in published peer reviewed literature results have found heart birth
defects associated with Zoloft use. Dr. Jewells methodology and even his basic conclusions
were further confirmed by a power point presentation prepared by Pfizer employee25 Francesca
Kolitsapoulis entitled Epidemiology Review of published literature on Sertraline Use and
Teratogenic Effects in Pregnancy which says:
Epidemiological studies have shown that infants born to women who had first trimester
paroxetive exposure had an increased risk of cardiovascular malformations.26
The defense concedes that if it had been properly performed, Dr. Jewells purported
methodology was appropriately scientific. Although Dr. Jewells methodology facially comports
with defendants view of proper methodology, the defense claims these proper factors were so
improperly evaluated that his deviations from proper evaluation rises to the level of no scientific
evaluation at all.

24 N.T., 2/13/13 pm at 6:17 21.

25 The defense has stipulated that the scientific investigators involved in the internal studies presented
by plaintiff at the Frye hearing were appropriate Pfizer employees qualified to reach scientific
conclusions.
26 An accurate conclusion reached through an improper methodology should be rejected and not presented for
jury evaluation. A conclusion the Court deems inaccurate reached through a proper scientific methodology is
admissible in evidence subject to destructive cross examination before a jury. No explanation of any differences
between the methodology utilized by Dr. Jewell and the methodology utilized by Pfizers employees who reached
comparable conclusions was offered into evidence at the Frye hearing.

Defendant primarily presents three issues.27 The defense claims Dr. Jewells
methodology is inadequate because of his improper assessment of confounding. The defense
claims that Dr. Jewells analysis improperly considered studies which have overlapping
populations as if they were separate studies. The defense claims that Dr. Jewell improperly
groups or lumps cardiac birth defects.
The gold standard study is the randomized control trial in which the outcome of two
comparable populations are identified and one is exposed to the medication. All agree that this
gold standard cannot be ethically done concerning Zoloft in pregnant women. Thus, the studies
from which conclusions can be dawn are observational studies. The parties agree on the relevant
observational studies and substantially agree on the subgroup of observational studies which find
an association between Zoloft and cardiac birth defects. Two Pfizer documents offered into
evidence analyzed the same observational studies as plaintiffs expert and reach comparable
conclusions from those studies.
Dr. Kimmel agreed that Dr. Jewells methodology in determining whether the studies had
replicated results was proper. Nonetheless the defense claims there are problems in Dr. Jewells
evaluation of replication. The defense contends that since three studies have overlapping
populations these studies cannot demonstrate replication.
Dr. Jewell acknowledged the overlapping populations but applied his expertise to
determine that since they only partially overlap they nonetheless confirm and replicate the
findings. Dr. Kimmel admitted that plaintiffs experts consistency and replication opinions were
confirmed by other study authors.

27 Other issues have been raised and are therefore preserved for all future purposes but are overruled
without need to be specifically addressed in this Memorandum Opinion.
9

Q. Dr. Jewell notes in his report that Pedersen concluded in his paper that agreement
with data from a different population with a different type design is reassuring for the
validity of our results. That shows some consistency in replication correct?
A. Thats what Dr. Pedersen says in his paper.
Q. Correct and that one of the papers you relied upon correct?
A. But its only one of many papers that.
Q. is it correct or incorrect?
A. Yes its correct. 28
The question of overlapping populations presents a proper topic for cross examination but
not such a methodological defect as to warrant preclusion.
Defendants contend that Dr. Jewells use of not statistically significant data as a
supporting trend is impermissible. However, Dr. Kimmel agrees that not statistically significant
results could, if appropriately evaluated, support consistency.
Q. Well can a non-significant results ever be used to support consistency in your
professional opinion?
A. Sure, as long with all the other data that are inconsistent.
Although Dr. Kimmel himself does not consider not statistically results as a supporting trend
he does concede that some experts consider this methodologically appropriate.
WITNESS:The term supporting trend is something that I actually did teach against
because it leaves you up to total interpretation of what you believe of the
number, so I cannot say thats a supporting trend. That would be against
my teaching.
COURT:
Do others teaching epidemiology teach the supporting trend process that
you dont teach?
WITNESS: Possibly.
COURT:
Youre not sure?
WITNESS: Im not sure. Im not sure.
COURT:
Why do you say possibly then?
WITNESS: Well, I dont sit in on classes. I dont know what everybody teaches.
COURT:
Yeah, but is there literature about it?
WITNESS: Oh, there are definitelyCOURT:
And therefore, some might be using that literature to teach.
WITNESS: People will use that term for those values of P values.

28 N.T., 2/18 71/12-24.

10

Q:

.
A:

Do you believe that this statement as set forth here about statistical
significance and nonsignificant results, that you can indeed take
significant results and results that are not significant and use those to show
a consistent affect?
I agree that you can do it29

Q.And so in this paper, you relied upon insignificant results or nonsignificant results to
support consistency; is that correct?
A.
In this example, yes.
Q.
Is that a valid methodology?
A.
Assuming you look at all the data and not just pick the ones that are
consistent with your theory.30
The defense claims Dr. Jewell improperly lumped birth defects because Mia
Robinsons primary cardiac birth defect was transposition of great arteries (TGA). The
defense contends that causal conclusions can only properly be drawn from studies which showed
an association between Zoloft and TGA. The defense claims that only statistically significant
results for her most serious heart defects, TGA, should be used to demonstrate causation.
TGA is an exceptionally rare birth defect. The sample of birth defects in published
studies segregated as to TGA alone are simply insufficient in number for a statistically
significant association to be revealed. Most studies did not segregate TGA as a separate birth
defect. Thus grouping or lumping is not claimed to be per se improper. The defense concedes it
may be appropriate to lump or group cardiac defects for certain purposes.
Dr. Kimmel specifically testified that lumping could be a proper methodology.
Q. And would it be proper to lump all the heart defects that occur in children births
when theyre born, would that be a proper methodology.
A. Its not improper, but its--29 N.T., 2/18/2015 p.m. at 53/16-22.
30 N.T., 2/18/2015 p.m. at 53/16-22.
11

Q. Does not improper mean proper or is that different.

A. It is proper assuming that you also look at the specific defects and treat those in the
proper way. Its one proper way of doing looking at the data.
The issue is whether an appropriate grouping was used by Dr. Jewell. The question as to
general causation presented in this case is whether Zoloft taken during pregnancy can be the
cause of any cardiac defect suffered by Mia Robinson at birth.
Dr. Jewell conceded that there is insufficient information to isolate TGA birth defects.
Likewise, the defense agrees that the TGA birth defects isolated in the studies are too few for
statistically significant associations to be found. The failure to find statistically significant
results is because of the size of the populations in the studies and the infrequency with which
TGA birth defects occur. Specific birth defects can be so finely isolated that insufficient
numbers exist to ever demonstrate statistically significant results.
Dr. Kimmel agreed that birth defects can be differentiated so finely that no statistically
significant results can be demonstrated. Dr. Kimmel further agreed that appropriate and
scientific studies properly grouped TGA with other birth defects.
Under those circumstances logic dictates and proper scientific methodology approves the
necessity of grouping results. Not only was this methodology used by Dr. Jewell but also used
by investigators in peer reviewed published studies, defendants experts, and Pfizers
employees.31 If adverse consequences are finely differentiated statistically significant cannot be
found because of an insufficiently number of examples. As the Superior Court insightfully
recognized:
Thus, a cause-effect relationship need not be clearly established by animal or
epidemiological studies before a doctor can testify that, in his opinion, such a
31 While the precise methodology of Pfizer employers has not be fully explained, it appears that they
have grouped or lumped birth defects.
12

relationship exists. As long as the basic methodology employed to reach such a

conclusion is sound, such as use of tissue samples, standard tests, and patient
examination, products liability law does not preclude recovery until a statistically
significant number of people have been injured or until science has had the time and
resources to complete sophisticated laboratory studies of the chemical. In a courtroom,
the test for allowing a plaintiff to recover is not scientific certainty but legal
sufficiency. That [a] case may have been the first of its exact type, or that [a plaintiffs]
doctors may have been the first alert enough to recognize such a case does not mean that
the testimony of [the experts] . Should not have been admitted.32
Sometimes proper scientific conclusions must be extrapolated from available data. In
Trach v. Fellin, the Superior Court held that where the opportunities to examine a specific cause
and effect relationship are limited, extrapolation from analogous studies is permissible. A
number of applicable studies utilize the EUROCAT classification system which lump or group
birth defects. Dr. Kimmel agreed that the EUROCAT classification system was properly
scientific.33 Dr. Kimmel agreed that the studies which demonstrated associations with heart
defects generally could not show association with specific heart defects. He explained:
So one possibility is just a power issue right. So you have fewer numbers of individual
defects. And thats what the EUROCAT was saying, dont look at every single line
items, put them together so you will at least have enough within a physiologic,
biologically plausible---.
Dr. Kimmel agreed the Jimenes-Solom Peer Review articles properly grouped or lumped
heart defects.34 He also agreed that lumping TGA with other hearts defects as a category, as in
the Huybrechts study was proper.35
32 Trach v. Fellin, 817 A.2d 1102 at 1117 (quoting Ferebee v. Chevron Chemical Co., 736 F.2d 1529,
1535-36 (D.C. Cir. 1984), cert. denied, 469 U.S. 1062 (1984)).
33 N.T., 2/18 15 117 5-7 118: 5-20.
34 N.T. 2/18 15 111: 16-25.
35 N.T., 2/18 15 8:13-20.
13

Q. So if you wanted to get any information about TGA from these studies you would
have to lump that category with others wouldnt you?
A. Thats whats beenwell that is------well, thats whats been done in Huybrechts and
some of the other studies, thats correct.
Dr. Kimmel concedes, as he must, there is a balance to be struck between lumping
together heterogeneous sets of anomalies and splitting so finely that there are few cases in each
group. 36
The Superior Court decision in Trach v. Fellin, is exceptionally instructive where the
limitations of scientific studies and the impossibility of ethically having a gold standard
methodology requires a practical evaluation. The Court recognized that courts do not require
perfection.
In Trach v. Fellin, the plaintiff was given the wrong medication by the defendant Thrift
Drug. Although the plaintiff was prescribed an antibiotic, he ingested six times the maximum
permissible dosage of an anti-depressant. Of course there never could be any studies to
determine the long term effects of taking six times the maximum permissible dosage of an antidepressant medication. Plaintiffs expert testified by extrapolating from the known side effects
of the medication taken to opine as to the long term effects. The Trach Court said:
..in fact, it is a logical method used to estimate the value of a variable outside its
tabulated or observed range or to infer (that which is not known) from which is
known.37
The Trach court discussed at length the case of Donaldson v. Central Illinois Public
Services Co.,38 in which:

36 N.T. 2/18 15 118/5-8.

37 Trach v. Fellin, 2003 Pa. Super. 33, 817 A.2d 1102, 1114 (2003).
14

the scientific community had been limited by the small number of neuroblastoma
cases and its abilities specifically to link exposure to coal tar with development
neuroblastoma.
The experts in that case extrapolated from similar but not identical studies and theories to
conclude that coal tar exposure caused the childrens neuroblastoma. That court said:
..extrapolation is commonly used by scientists in certain limited instances;
for example, when the medical inquiry is new or the opportunities to examine a specific
cause and effect relationship are limited; when the number of cases limits study of the
disease; or, as noted supra, when ethical considerations prevent exposing individuals to a
toxic substance for research purposes. Id. At 85 87, 262 Ill.Dec. 854, 767 N.E.2d at 328,
330. Accordingly, to the Donaldson Court, when an expert relies upon scientific literature
discussing similar, but not identical, cause and effect relationships, the fact that the expert
must extrapolate affects the weight of the testimony rather than its admissibility. Id. At
85, 262 Ill.Dec. 854, 767 N.E. 2d at 328 citation omitted).
The Superior Court also quoted favorably from the case of Ferebee v. Chevron Chemical Co.39:
Thus, a cause-effect relationship need not be clearly established by animal or
epidemiological studies before a doctor can testify that, in his opinion, such a relationship
exists. As long as the basic methodology employed to reach such a conclusion is sound
such as use of tissue samples, standard tests, and patient examination, products liability
law does not preclude recovery until a statistically significant number of people have
been injured or until science has had the time and resources to complete sophisticated
laboratory studies of the chemical. In a courtroom, the test for allowing a plaintiff to
recover in a tort suit of this type is not scientific certainty but legal sufficiency; if
reasonable jurors could conclude from the expert testimony that paraquat more likely
than not caused Ferebees injury, the fact that another jury might reach the opposite
conclusion or that science would require more evidence before conclusively considering
the causation question resolved is irrelevant. That Ferebees case may have been the first
of its exact type, or that his doctors may have been the first alert enough to recognize
such a case, does not mean that the testimony of those doctors, who are concededly well
qualified in their fields, should not have been admitted.
The Superior Court concluded:
as long as the basic methodology is sound the scientist may extrapolate from this
sound scientific basis when it is either impossible or unethical to perform the sorts of
clinic trials that would yield definitive results.
38 767 N.E.2d 314 (2002).
39 736 F.2d 1535-1536 (D.C. Cir. 1984).
15

Defendants claim that although plaintiffs experts facially utilize an acceptable

methodology the manner in which they applied this acceptable methodology is unacceptable.
Thus the question presented by Defendants in this Frye motion can be understood as when does a
difference in degree become a difference in kind as to require preclusion. This Court concludes
that the differences presented here are differences in degree of a proper methodological analysis
and not differences in the kind of analysis performed such that the methodology is improper.
The issues and considerations presented in defendants Frye motions are certainly appropriate for
effective cross examination but preclusion is not warranted. The Frye motions as to general
causation are denied.

SPECIFIC CAUSATION

Plaintiffs specific causation experts opine that Mia Robinsons cardiac birth defects were
caused by exposure to Zoloft in utero. They base this opinion on their experience and clinical
judgment. A physician must use clinical judgment and expertise to determine the possible cause
of birth defects. This is vital for the physician to properly advise their patients who may wish to
consider a second pregnancy. There is nothing novel about clinical judgment testimony.40 In
Kendal v.Wyeth, Inc41. the Pennsylvania Superior Court said: certainly differential diagnosis is a
generally accepted methodology.42
40 See Haney v. Panonelli, Pa. Super. 261, 830 A.2d 978 (2003).
41 1154 EDA 2010, 2012 WL 112609 (Pa. Super. Ct. 2012).
42 See also, Snizavich v. Rohm Haas, 2013 Pa. Super. 315, 83 A.3d 191 Pa. Super 2013.
16

Dr. Abdullah, plaintiffs expert ruled out other medications, diabetes, gestational diabetes,
obesity, smoking, alcohol use, illegal drug use and second hand smoke as causes of Mia
Robinsons cardiac defects at birth. Dr. Abdullah also ruled out genetics. Likewise, Dr.
Vekemans followed a similar approach. Their clinical judgment opinion is admissible.
The Court notes that once the Court concludes that general causation opinion is admissible
opinion on specific causation may readily follow. In the case of Klein v. Aronchick,43 plaintiffs
experts had testified to direct causation. Nonetheless the Superior Court found reversible error
because the trial court refused to give an increased risk of harm jury charge. In that case
plaintiffs expert report stated and the expert testified in court to a reasonable degree of medical
certainty that the defendant doctors over prescription of medication had directly caused
plaintiffs kidney disease. The trial court refused to allow the expert who had offered such a
definitive opinion as to direct causation to also testify that taking too many drugs had also
increased the risk of kidney damage.
The Superior court said:
although preferred the expert is not necessarily required to use the magic words of
increased the risk so long as the opinion is expressed to the requisite degree of medical
certainty.
The court held the plaintiff should have been permitted to argue increased risk of harm and a jury
charge as to increased risk of harm should have been given.
It is of course a logical necessity that anything which actually causes a result must have
increased the risk of causing that effect. Thus, the Superior Court instructs that when general
causation testimony uses proper methodology and plaintiff presents actual causation evidence, if

43 85 A.3d 487 (2014).

17

requested, a charge on increased risk of harm must be given. This jury instruction must be given
even if never explicitly mentioned in the causation experts reports or testimony.
Since this court has found that the opinion that Zoloft can cause heart birth defects is
permissible it is logically and necessarily permissible that specific causation experts be permitted
to testify and plaintiff permitted to argue that the ingestion of Zoloft during pregnancy increased
the risk of birth defects of the heart. It then becomes a jury question as to whether that increased

18

risk presented by Zoloft was a factual cause of any specific heart birth defect. Plaintiffs specific
causation experts may testify.

BY THE COURT

_________
DATE

_____________________________
MARK I. BERNSTEIN, J.

19